Helen Critchley, Country Regulatory Head – Australia & NZ, Sanofi
Helen Critchley, Country Regulatory Head – Australia & NZ, Sanofi, at a session of the Asia Regulatory Conference, shared the importance of universal labeling and e-labeling in promoting digital transformation and global harmonization. She also explained the challenges and opportunities associated with adapting medicine labeling to the digital era with focus on the benefit of supply chains streamlined by standardized iconography and overcoming language barriers. Following are the key insights from her address.
In the context of global packaging, the concept of universal labelling focuses only on presenting critical information. The key thing is to identify, authenticate, and ensure integrity by knowing the trade name, the strength, the formulation, or the dosage form, how to store the product, and whether it has a data matrix code, which may indicate serialization. In addition, having a global standard iconography is essential because today, it is not words that help patients understand things. It is much more about pictures. Under this concept of universal labelling, when the patient travels around to other places on the globe, it is a much simpler proposition for such familiarity to have quick recognition of that particular patient’s medicine. No country information shall appear on the pack but only either via digital codes or a QR data matrix, which in any event can develop later, may develop faster. Additionally, Electronic Product Information (EPI) will already be up-to-date, reflecting the industry’s move to a future-ready state.
Country-specific details are usually in paper format and put in a dedicated section of the pack. One example is the EU blue box. In the EU, upon the approval of a new drug through the central procedure, all packs contain common information, which can be verbatim translated beyond the English language. All country-specific information is put into a dedicated section of the pack. A similar approach is all country-specific information, from multiple language levels, accessed through digital, such as QR codes or data matrix codes.
The focus on universal labeling now extends to every leaflet with the packaging, the cartons and the product labels themselves. The focus on universal labeling now extends to every leaflet, including the packaging, cartons, and product labels themselves. In COVID, not only were the leaflets accessed by QR code, but it wasn’t possible to do all the unique country-specific labels, nor was it possible to get an awful lot of information on small vaccine vials. So, universal labels were also critical to managing the supply chain.
Acknowledging that a pandemic can again occur, one should be better prepared in case of any pandemics, simplifying the supply chain. By simplifying the supply chain, it reduces all the downtime in manufacturing, in countries, if countries can all take a common pack; it's much quicker to resolve medicine shortages. And once the product is created, have that accessible to all countries rather than need to wait for country-specific information. Reducing unique components in packaging not only simplifies the chain but also reduces waste. Packaging components, unlike leaflets, are less frequently changed, but changes do happen, such as an update to the instructions on storage or design of the label. Adopting a global approach to labelling can reduce the wastage of all these country-specific things. By embracing universal labeling, the pharmaceutical industry can assist in sustainability in the delivery of medicines across the globe.
Universal labelling is an idea that has many benefits for patients, especially in terms of alignment with a digital ecosystem. The current medicines labelling is driven by regulations that were created during the paper era. This historical reliance on paper has slowed the transition to digital. However, it is essential to build trust and confidence in accessing and using information appropriately in the digital world. Iconography is a tool that effectively communicates key messages. For instance, a "do not use during pregnancy" on a label might be substituted for an icon consisting of a pregnant woman with a red cross superimposed across it. These icons are effective for low-literacy patients as well, who recognize important warnings to seek further help or training.
The adoption of universal labelling requires the standardization of iconography. This is on top of the Electronic Product Information framework, in which accessing information digitally becomes the norm. Supply chains can have constraints when need to make small volumes for countries. And where there can’t be an accommodation for countries to accept non-unique products, it could sometimes be a barrier and almost unviable to make the quantities that are so small for an individual country and take all that downtime. Universal labelling simplifies the supply chains, besides helping patients understand their drugs easily. The same packing guarantees easier and more effective monitoring and surveillance on an international scale. This concept has the identification of extra products such as IGMP.
The idea of universal labelling comes with opportunities and challenges. Technologies are fast evolving in fields such as banking and home appliances, which include accessing instructions on the Internet. Even though such sectors come with significant safety risks than what is being discussed for medicines, they represent how increasing reliance has shifted towards digital formats. Most of the regulations in use currently were formed in a pre-digital age. The International Council for Harmonisation (ICH) has harmonised quality, safety, and efficacy. However, the results of these assessments of prescription and consumer information have not addressed the uniformity of requirements for cartons or product labels concerning product integrity. Uniformity of these requirements would better the supply chain and create a common form of transference of information to patients everywhere in the world. Although the presentation and arrangement of the information would depend on the country, for instance, on the zones of temperature, the details should remain the same. This way, patients may easily access useful information like storage requirements, the name of the drug, and the strength regardless of their location.
Integration of labeling into a broader digital ecosystem is a critical shift. Key information may then migrate from physical labels to digital sources, such as EPI, avatars, or medicine spots, and all those things that can connect in that digital ecosystem. In the real world, patients primarily rely on information from the prescription medicine label by their pharmacy, so the minimal utility of an unnecessary word would be on the original product label. In hospitals, patients most of the time do not view the pack. Achieving the harmonisation of medicine legislation is a long stage and time consuming and complex, but it also leads to several benefits, including more effective use of resources and encouraging innovative activities. For both industry stakeholders and regulators, it is a key focus for today’s global harmonisation.
Global labeling takes into account language differences. Product name, strength, dosage form, and storage conditions are critical to help patients identify the product and store it properly. Not everyone can read and understand English; therefore, a product with universal labeling should be accepted in countries like Asia, Russia, China, and Saudi Arabia. This is a world where everything is digital. A patient will be able to access their Electronic Product Information using a single data matrix code. Though the product might show information in English, the data matrix will have the necessary information in Russian, Chinese, Arabic, and so on. This strategy is a continuation of the shift into the digital ecosystem. Starting universal labeling in areas such as hospitals where the patient doesn’t see the label is how to start introducing the staged approach, etc. People are used to accessing information with the use of codes already. For instance, one can purchase something from another country having a label written in another language but can scan a code to retrieve an English version.
To address the problems, a good starting point for global conversation will be required through forums like ICH so that one knows where the barrier exists and how to address them. Therefore, the aim would be to see to it that no matter where or what the country or language, the needed information is provided for all the patients. In countries like Australia, where most labels are in English, there are systems in place for providing translated versions for individuals who struggle with English. This reflects the reality that many people, regardless of the country, may face language barriers when reading medicine labels.
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